Philips Respironics Recalls Ventilators
Just weeks after a recall of its continuous positive airway pressure (CPAP) devices, Philips Respironics is recalling certain ventilators it manufactures.
The recalled V60 and V60 Plus ventilators provide high-flow oxygen therapy and are operated with software versions 3.00 and 3.10.
The recall is due to the risk to patients if the system pressure reaches a default maximum when the oxygen flow is partially blocked for any reason. If the problem is not resolved by the healthcare provider, the ventilator will continue to provide the patient with lower oxygen flow rate.
The FDA has deemed the recall Class I because of the risk of serious injuries or death to patients. The agency said there have been 61 incidents, 25 injuries, but no deaths reported in connection with the problem.